Spots Global Cancer Trial Database for Study to Assess AFM24 in Advanced Solid Cancers
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Trial Identification
Brief Title: Study to Assess AFM24 in Advanced Solid Cancers
Official Title: A Phase 1/2a Open Label, Multicenter Study to Access the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AFM24 in Patients With Advanced Solid Tumors
Study ID: NCT04259450
Conditions
Interventions
Study Description
Brief Summary: AFM24-101 is a first in human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study evaluating AFM24 as monotherapy in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24 is a tetravalent bispecific (anti-human EGFR x anti-human CD16A) innate immune cell engaging recombinant antibody construct being developed to target EGFR-expressing solid tumors and has been designed to specifically utilize the cytotoxic potential of the innate immune system, in particular natural killer cells and macrophages for the specific and efficient elimination of EGFR-positive cancer cells.
Detailed Description: There will be two parts to this study: a dose escalation phase (1) and a dose expansion phase (2a). The aim of the dose escalation phase is to determine the maximum tolerated dose (MTD) and establish the recommended Phase 2a dose (RP2D). The dose escalation phase will be followed by the dose expansion phase once the MTD/RP2D of AFM24 monotherapy has been determined. The dose expansion phase of the study using the MTD/P2D is intended to collect preliminary evidence of efficacy and to further confirm the safety of AFM24 as a monotherapy. The expansion phase will have 3 arms based on tumor type. * Renal cell carcinoma(clear cell), failing standard of care (SoC) that includes TKIs and PD1 targeted therapy * Non-small cell lung cancer (EGFR-mut), failing SoC TKIs * Colorectal cancer , failing chemotherapy plus EGFR targeted antibodies
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Southern California, Los Angeles, California, United States
Dana Faber Cancer Institute, Boston, Massachusetts, United States
Nordwest Hospital GmbH, Frankfurt am Main, Hessen, Germany
University Duisburg-Essen, University Hospital Essen, Essen, , Germany
University Hospital Hamburg-Eppendorf, Hamburg, , Germany
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital, Suwon, , Korea, Republic of
Vall d'Hebron Institute of Oncology, Barcelona, , Spain
University Hospital Foundation Jimenez Diaz, Madrid, , Spain
University Hospital HM Sanchinarro, Madrid, , Spain
Hospital Clinic Universitario Biomedical Research institute INCLIVA, Valencia, , Spain
Institute of Cancer Research - Royal Marsden, London, , United Kingdom
Contact Details
Name: Michael Emig, MD
Affiliation: Affimed GmbH
Role: STUDY_DIRECTOR
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